End of EU MDR Article 120 transition period — Class IIb implantable legacy devices
2027-12-31 — End of EU MDR Article 120 transition period — Class IIb implantable legacy devices
Under Regulation (EU) 2024/1860, Class IIb implantable devices (excluding sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) that hold a valid MDD/AIMD certificate must obtain EU MDR conformity assessment by 31 December 2027 to continue to be placed on the EU market.
Manufacturers relying on legacy MDD/AIMD certificates for Class IIb implantable devices must have a valid EU MDR certificate in place before this date. Engage your Notified Body immediately to confirm your MDR conformity assessment timeline — NBs remain heavily capacity-constrained. Devices without a valid EU MDR certificate after this date cannot be placed on the EU market or put into service.
View official source ↗